A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered with Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral experienced, HIV-1 Infected Subjects

INTERVENTION: Product Name: Lopinavir/Ritonavir Tablets Product Code: D0600166 Pharmaceutical Form: Tablet INN or Proposed INN: lopinavir/ritonavir Current Sponsor code: ABT‐378 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200/50‐ CONDITION: Antiretroviral experienced, HIV‐1 Infection. Adequate ICD classification code not available. ; MedDRA version: 8.1 Level: LLT Classification code 10020192 Term: HIV‐1 PRIMARY OUTCOME: Main Objective: The primary objectives of this study are to compare the safety, tolerability and antiviral activity of QD and BID dosing of the lopinavir/ritonavir tablet formulation in subjects with detectable viral load while receiving their current antiretroviral therapy.; Primary end point(s): The primary efficacy variable will be the proportion of subjects responding (i.e., not demonstrating virologic failure) at Week 48. Secondary Objective: The secondary objective of this study is to characterize the development of resistance in QD and BID dosing of the lopinavir/ritonavir tablet in antiretroviral‐experienced subjects.; INCLUSION CRITERIA: A subject will be eligible for study participation if he/she meets the following criteria: 1. Subject is at least 18 years of age. 2. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study‐specific procedures are performed. 3. Subject agrees not to take any medication during the study, including over the counter medicines, vitamins, minerals, herbal preparations, alcohol or recreational drugs without the knowledge of the principal investigator. 4. Subject does not require and agrees not to take any drugs that are contraindicated with study drugs during the course of the study. For complete information, refer to the most current product label for locally approved prescribing information for lopinav